Trial Review

Please note that the ANZCTR website will be unavailable from 1:00pm until 2:00pm (AEST) on Thursday 10th of April for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.


The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000153910
Ethics application status
Approved
Date submitted
3/02/2011
Date registered
9/02/2011
Date last updated
23/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Early Cardiac Changes During Chemotherapy in Breast Cancer
Scientific title
Early Cardiac Changes During Anthracycline and/or Trastuzumab Therapy in Breast Cancer
Secondary ID [1] 253546 0
None
Universal Trial Number (UTN)
U1111-1119-2755
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy induced Cardiomyopathy 261098 0
Breast Cancer 261126 0
Condition category
Condition code
Cardiovascular 259230 259230 0 0
Other cardiovascular diseases
Cancer 259231 259231 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cardiac MRI, Echocardiography, serum biomarkers at baseline, 1 month (during chemotherapy), 3 and 12 months (post chemotherapy). This will take approximately 90 minutes. We will perform these interventions to identify sub-clinical changes of probable significance for development of later manifest ventricular dysfunction.
Intervention code [1] 257994 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262067 0
Reduction in global longitudinal strain as measured by 2D speckle and Tissue velocity echocardiography (comparison will be made between baseline and 3 month scans).
Timepoint [1] 262067 0
baseline and 3 month scans
Secondary outcome [1] 273080 0
Presence and magnitude of myocardial fibrosis (as % of total LV mass) as assessed by 12 month CMR scan
Timepoint [1] 273080 0
12 month CMR scan
Secondary outcome [2] 273081 0
Presence and magnitude of myocardial oedema (as % of total LV mass) as assessed by 1 and 3 month CMR scan
Timepoint [2] 273081 0
1 and 3 month CMR scan
Secondary outcome [3] 273082 0
Reduction in global radial and circumferential strain as measured by 2D speckle and Tissue velocity echocardiography(comparison will be made between baseline and 3 month scans).
Timepoint [3] 273082 0
baseline and 3 month scans
Secondary outcome [4] 273083 0
Increase in Troponin T at 1 and 3 months, will be detected in a subset of patients that corresponds to increased signal intensity on STIR imaging and late gadolinium at 3 months
Timepoint [4] 273083 0
1 and 3 months

Eligibility
Key inclusion criteria
All patients with new diagnosis of HER2 positive early breast cancer planned for standard chemotherapy with anthracyclines and/or trastuzumab, or, patients with recurrent breast cancer planned for chemotherapy with anthracyclines and/or trastuzumab that have not had chemotherapy in the last 5 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with recurrent breast cancer that have received chemotherapy in the last 5 years, patients that don't meet safety requirements for cardiac MRI.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/07/2010
Actual
5/08/2010
Date of last participant enrolment
Anticipated
Actual
12/10/2012
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
100
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 3608 0
5042
Recruitment postcode(s) [2] 3609 0
5000
Recruitment postcode(s) [3] 3610 0
5037

Funding & Sponsors
Funding source category [1] 258427 0
Hospital
Name [1] 258427 0
Flinders Medical Centre
Country [1] 258427 0
Australia
Primary sponsor type
Individual
Name
Professor Joseph Selvanayagam
Country
Australia
Secondary sponsor category [1] 257575 0
None
Name [1] 257575 0
Country [1] 257575 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260410 0
The Southern Adelaide Health Service / Flinders University Human Research Ethics Committee
Ethics committee address [1] 260410 0
Ethics committee country [1] 260410 0
Australia
Date submitted for ethics approval [1] 260410 0
19/01/2010
Approval date [1] 260410 0
29/03/2010
Ethics approval number [1] 260410 0
24/10/2011

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32163 0
Prof Joseph Selvanayagam
Address 32163 0
Flinders Drive. Bedford Park, SA 5042
Country 32163 0
Australia
Phone 32163 0
+61 8 8204 5619
Fax 32163 0
Email 32163 0
joseph.selva@sa.gov.au
Contact person for public queries
Name 15410 0
suchi grover
Address 15410 0
Flinders Clinical Research - Imaging Level 3A Mark Oliphant Building Laffer Drive BEDFORD PARK SA 5042
Country 15410 0
Australia
Phone 15410 0
+61 8 8201 7700
Fax 15410 0
+61 8 8201 7701
Email 15410 0
kate.schwartz@health.sa.gov.au
Contact person for scientific queries
Name 6338 0
Dr Suchi Grover
Address 6338 0
Flinders University C/O Flinders Clinical Research - Imaging Level 3A Mark Oliphant Building Laffer Drive BEDFORD PARK SA 5042
Country 6338 0
Australia
Phone 6338 0
+61 8 8201 7700
Fax 6338 0
+61 8 8201 7701
Email 6338 0
suchi.grover@health.sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.